ROcuronium Bromide 50 mg/5 mL recall: CGMP Deviations
ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC…
Why was ROcuronium Bromide 50 mg/5 mL recalled?
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 20230524-530F73, Exp 21OCT2023
- Product
- ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC…
- Recalling firm
- New England Life Care, Inc. dba Advanced Compounding Solutions
- Quantity
- 500 Syringes
- Distribution
- Nationwide in the USA
- Recall date
- July 26, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)